| CTRI Number |
CTRI/2025/12/098393 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing usefulness of Magnesium Given by Drip or Nebulizer to Control Blood Pressure and Heart Rate changes During Intubation in Surgery undergoing general anaesthesia |
|
Scientific Title of Study
|
Effect of Intravenous versus Nebulized Magnesium Sulphate on Hemodynamic response to Laryngoscopy and Intubation in Adult Patients undergoing Elective Surgery : A Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arpith A G |
| Designation |
PG Resident |
| Affiliation |
Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
M S Ramaiah Nagar MSRIT Post Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
7204089495 |
| Fax |
|
| Email |
arpithg01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yatish B |
| Designation |
Professor |
| Affiliation |
Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
M S Ramaiah Nagar MSRIT Post Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Yatish B |
| Designation |
Professor |
| Affiliation |
Ramaiah Medical College |
| Address |
Department of Anaesthesiology
Ramaiah Medical College
M S Ramaiah Nagar MSRIT Post Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ramaiah Medical College M S Ramaiah Nagar MSRIT Post Bangalore 560 054 |
|
|
Primary Sponsor
|
| Name |
Ramaiah Medical College |
| Address |
M S Ramaiah Nagar MSRIT Post Bangalore 560 054 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arpith A G |
Ramaiah Medical College Hospital |
Department of Anaesthesiology M S Ramaiah Medical College M S Ramaiah Nagar MSRIT Post Bangalore 560 054 Bangalore KARNATAKA |
7204089495
arpithg01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College and Hospitals Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Magnesium Sulphate |
IV Magnesium Sulphate 30mg/kg given in pre operative room. |
| Intervention |
Nebulized Magnesium Sulphate |
Magnesium Sulphate 30mg/kg given through nebulization mask in pre operative room. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Aged 18–65 years with American Society of Anaesthesiologists classification I-II Scheduled for elective surgery under general anaesthesia with endotracheal tube insertion. |
|
| ExclusionCriteria |
| Details |
Anticipated difficult laryngoscopy and intubation
Patient with cardiovascular dysfunction or arrythmias
Hepatic or renal impairment
Neuromuscular disorder
Raised intracranial pressure or intraocular pressure
Presence of preoperative oral ulcer, sore throat, pharyngitis
Pregnant patients
Patients allergic to magnesium sulphate.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean arterial pressure [MAP] and Heart Rate [HR] |
Mean arterial pressure [MAP] and Heart Rate [HR] at baseline, at the time of
study drug administration, 5, 10, and 15 minutes after starting administration of the study drug,
before induction, at the time of laryngoscopy, just after intubation, and 1, 5, and 10 minutes after
intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of propofol consumption |
During the
induction of anaesthesia |
| Incidence of Sore Throat |
Post Operative |
Any adverse effects of
magnesium sulphate, such as intraoperative bradycardia [HR 30 percentage fall from baseline, more more than 20 percentage fall in
MAP from baseline], and postoperative nausea, vomiting, or respiratory depression. |
Intra and Post Operative |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="7" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arpithg01gmail.com].
- For how long will this data be available start date provided 28-11-2027 and end date provided 01-01-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Laryngoscopy and intubation are essential procedures in general anaesthesia for airway management and ventilation but can trigger sympathetic stimulation, leading to increased heart rate, blood pressure, arrhythmias, and elevated intracranial or intraocular pressure. Various pharmacological and non-pharmacological interventions have been explored to control these hemodynamic changes, but no optimal method has been established. Magnesium sulphate possesses anaesthetic, analgesic, and muscle relaxant properties, acting as a calcium antagonist, NMDA receptor blocker, and inhibitor of catecholamine release. It also induces vasodilation and has antiarrhythmic effects. Intravenous magnesium sulphate has shown efficacy in reducing the adverse hemodynamic response during intubation but may cause side effects such as hypotension, bradycardia, and respiratory depression. Nebulized administration provides better mucosal absorption, fewer systemic effects, and improved patient comfort. This study aims to compare nebulized and intravenous magnesium sulphate in attenuating the hemodynamic response to laryngoscopy, hypothesizing that the nebulized route is not inferior. In this study, which is a randomized open label trial with a sample size of 84 that will be conducted in Ramaiah Medical College, Bangalore, we aim to compare the Effect of intravenous versus nebulized magnesium sulphate on hemodynamic response to laryngoscopy and intubation in adult patients undergoing elective surgery. The primary outcome of our study is to compare the HR and MAP following laryngoscopy and intubation. Monitoring of HR and MAP occurs at specific time points: at baseline, at the time of study drug administration, 5, 10, and 15 minutes after starting administration of the study drug, before induction, at the time of laryngoscopy, just after intubation, and 1, 5, and 10 minutes after intubation. Secondary outcomes include the comparison of propofol consumption during the induction of anaesthesia, incidence of Post Operative Sore Throat, and any adverse effects of magnesium sulphate, such as intraoperative bradycardia (HR 30 percentage fall from baseline, more than 20 percentage fall in MAP from baseline), and postoperative nausea, vomiting, or respiratory depression. |